Generally, chromatography is the collective term for a family of techniques that may be used in a laboratory in order to separate mixtures. This laboratory technique usually involves sending a mixture dissolved in a “mobile phase” through a stationary phase, where this stationary phase separates the analyte to be measured from other molecules in the mixture and allows it to be isolated.
There are several types of chromatography, such as gas or liquid chromatography. Gas chromatography is a separation technique in which the mobile phase is a gas. Gas chromatography is always carried out in a column, which is typically in a packed mode or capillary mode. Liquid chromatography is a separation technique in which the mobile phase is a liquid. The liquid chromatography can be carried out either in a column or a plane. Present day liquid chromatography generally utilizes very small packing particles and a relatively high pressure is referred to as high performance liquid chromatography
ÄKTAready™ is a liquid chromatography system using disposable flow paths, i.e. ÄKTAready™ flow paths, manufactured by GE Healthcare in Uppsala, Sweden. The ÄKTAready™ system is based on proven liquid chromatography techniques, such as ion exchange, affinity chromatography, and hydrophobic interaction. This ÄKTAready˜ system includes a disposable flow path system with UNICORN™ software that enables it to perform automated liquid chromatography. The system is characterized by a re-usable instrument that is equipped with a clean, preferably pre-sterilized, flow path prior to operation. By exchanging the flow path in between chromatographic runs and processes, the need for cleaning, cleaning validation and the risk for cross-contamination is eliminated. The flow path comprises all wetted parts in fluid contact during operation, including tubing, sensor components, fluid treatment components (e.g. air trap) and connectors.
However, there are problems with using the disposable flow path system in the ÄKTAready™ system, because the manual interaction of the user with the system during replacement of the disposable flow path may lead to improper installation (or removal) of components of the flow path system. For example, the availability of different tubing sizes of the flow path components may lead to malfunction of the system if wrong parts are installed by the user and there is no procedure for automatic recognition of the flow path components in place that may prevent the user from using a wrongly installed system. Also, if the components are not installed properly then the analyte may not be properly measured from other molecules and it may not be isolated. Additionally, there is a problem of qualifying newly installed flow path components according to their specification limits, i.e. the sensor components, prior to the chromatographic run in a safe and failure proof manner.
Further, there is another problem with the disposable flow path in that a “traditional” Installation Qualification and Operation Qualification would “contaminate” the flow kit and it would not be “clean” enough to be used for purification without doing a cleaning in place procedure. With the ÄKTAready™ system the Installation and Operation Qualification are completed by utilizing the complementary flow kit to qualify the performance of the cabinet only.
Therefore, there is a need for a system and method that enables the user to install components of the flow path system and qualify the functionality of the system components in order for the analyte (or product) to be properly measured from other molecules in the mixture and to allows the analyte (or product) to be isolated as intended.